Senior Site Management Research Associate

Job Overview:

Job Summary: Provide training and direction to the Phase IV Solutions study team regarding adherence to Covance Standard Operating Procedures (SOPs), Project-specific Controlled Documents, FDA and ICH Guidelines, GPPs, and GCPs Oversee the development and maintenance of tracking systems for projects Oversee and perform investigative site recruitment/feasibility, essential document collection and review Oversee and provide in-house site management Conduct and provide training for centralized monitoring. Coordinate the assignment of site visits (centralized and/or on-site) as needed.  Additionally, review trip reports (centralized and/or on-site) as needed.  Work with Project Manager to develop and maintain study plans, train staff and ensure adherence to Data Management Plans and other applicable plans Assure the implementation of project plans as assigned Function as leader for projects of limited scope as assigned Assume supervisory responsibilities as assigned

Essential Job Duties:  Manage small projects under direction of a Project Manager/Director as assigned Serve as lead Site Management Associate for a protocol or project and may assist in writing, reviewing and implementing Protocols, Data Collection Tools, Project-specific Controlled Documents, Project Plans, Data Management Plans, Site Management Plan, Monitoring Conventions, clinical study reports, etc, as assigned Perform site evaluation and recruitment including, collection and review and close out of required critical documents from sites (including submissions and notifications to Institutional Review Boards or Ethics Committees (where applicable) by creating, updating, tracking, and maintaining study-specific trial management files, tools, and systems Support investigators in fulfilling their obligations with regard to submissions according to applicable local, regulatory, and IRB/IEC requirements Oversee negotiation and management of study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned Oversee and conduct training with sites on web-based applications; including but not limited to: Web-ex and Investigator Meetings Provide oversight and management of study sites to ensure adherence to the study design; support escalation process of site issues As assigned, act as primary point of contact for assigned study sites and retain primary responsibility for the resolution of all site issues Responsible for all aspects of site management as prescribed in the Site Management Plan and other related project plans Review progress of projects and initiate appropriate actions to achieve target objectives Communicate with internal work groups to evaluate needs, resources and timelines Act as primary contact for vendors and oversee the management of study supplies Responsible for all aspects of centralized monitoring including initiation, routine monitoring, and close-out of clinical sites via phone, web-based applications as applicable Ensure accurate and expeditious safety reporting in accordance to federal guidelines and sponsor and program requirements, as well as complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs Assist with training, mentoring and development of new employees Perform CRF review, query generation and resolution of queries to investigative sites/clients to resolve problem data against established data review guidelines on Covance or client data management systems, as assigned by management Independently review study data in accordance with Data Management Plans and applicable SOPs, etc., to identify erroneous, missing, incomplete, or implausible data Facilitate the aggregate review of study data by patient, site, and/or project to identify data trends and/or data inconsistencies that require further investigation Coordinate designated clinical projects (with supervision, if applicable), and may act as a local client contact as assigned Participate in business development or departmental improvement initiatives as assigned General Monitoring Responsibilities – Centralized: Pre-study, initiate, monitor and close out Investigator sites via phone including review of Case Report Forms Review site information and communicate with sites to resolve data discrepancies Develop training materials and conduct training for project team for centralized and/or on-site monitoring as required Develop training matrix and tracking for project related trainings Review trip reports for project team for centralized and/or on-site monitoring as required Perform other duties as assigned by management Education/Qualifications:

 Required:University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology. In lieu of the above requirement, candidates with four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered Thorough knowledge of ICH Guidelines, GCP and GPP including a basic understanding of regulatory requirements in other countries. Thorough understanding of the drug development process. Fluent in local office language and in English, both written and verbal Preferred:Thorough knowledge of Covance SOPs regarding site monitoring. Experience:Required:Minimum of four (4) years clinical research experience of centralized and/or on-site monitoring Have a full understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs Advanced study site management skills Advanced registry administration skills Ability to work with minimal supervision Good planning and organization skills Good computer skills with good working knowledge of a range of computer packages Advanced verbal and written communication skills Ability to train and supervise junior staff Ability to resolve project-related problems and prioritizes workload for self and team Ability to work within a project team Works efficiently and effectively in a matrix environment Preferred:      Local project coordination and/or project management. Have experience interacting with external clients, including contributing to or facilitating teleconferences or face to face meetings